FDA 510(k) Application Details - K981905

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K981905
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	ACU-PAK 2 PERIMETER RD., EAST LONDONDERRY, NH 03053 US Other 510(k) Applications for this Company
Contact	CAROL THOMPSON Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/1998
Decision Date	08/18/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review